Document Detail

Multicentre comparative study of two schedules of gabexate mesilate in the treatment of acute pancreatitis. Italian Acute Pancreatitis Study Group.
MedLine Citation:
PMID:  11303975     Owner:  NLM     Status:  MEDLINE    
AIM: To compare the efficacy of two different schedules of gabexate mesilate (900 mg/day, or 1,500 mg/day) in the treatment of severe acute pancreatitis. SETTING: Forty-two Italian medical and surgical centres took part in the study. STUDY DESIGN: A multicentre, prospective, open label, comparative, parallel-group, randomized study. METHODS: The patients enrolled in the study had acute pancreatitis as demonstrated by typical abdominal pain and baseline serum amylase concentrations more than twice the upper normal limit, findings compatible with acute pancreatitis at imaging techniques, and a Glasgow criteria score of > or =3. Patients were randomly assigned to one of the two schedules of treatment with gabexate mesilate being administered intravenously for at least 7 days. The minimum clinically relevant difference (delta), between groups, in incidence of complications due to acute pancreatitis, during the first month of the study treatment, was predefined as equal to 10%. RESULTS: A total of 199 patients were assigned to gabexate mesilate 900 treatment and 189 to gabexate mesilate 1,500. Complications developed in 88 patients within one month of beginning treatment 44/199: patients (22.1%) in the gabexate mesilate 900 group and 44/189 patients (23.3%) in the gabexate mesilate 1,500 group (difference 1.2%; 95% confidence interval: -7.2; 9.5%). CONCLUSIONS: Gabexate mesilate 900 mg per day is as effective as gabexate mesilate 1,500 mg per day in reducing the complications due to acute pancreatitis.
R Pezzilli; M Miglioli
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver     Volume:  33     ISSN:  1590-8658     ISO Abbreviation:  Dig Liver Dis     Publication Date:    2001 Jan-Feb
Date Detail:
Created Date:  2001-04-16     Completed Date:  2001-07-12     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100958385     Medline TA:  Dig Liver Dis     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  49-57     Citation Subset:  IM    
Emergency Department, Sant'Orsola Hospital, Bologna, Italy.
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MeSH Terms
Acute Disease
Dose-Response Relationship, Drug
Drug Administration Schedule
Gabexate / administration & dosage*,  adverse effects
Middle Aged
Pancreatitis / diagnosis,  drug therapy*,  etiology
Prospective Studies
Serine Proteinase Inhibitors / administration & dosage*,  adverse effects
Treatment Outcome
Reg. No./Substance:
0/Serine Proteinase Inhibitors; 39492-01-8/Gabexate
Comment In:
Dig Liver Dis. 2001 Jan-Feb;33(1):12-3   [PMID:  11303968 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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